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A Phase 2 Study of ASC-J9 Cream in Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT00525499
Recruitment Status : Completed
First Posted : September 5, 2007
Results First Posted : April 18, 2011
Last Update Posted : November 23, 2011
Sponsor:
Information provided by (Responsible Party):
AndroScience Corp

Tracking Information
First Submitted Date  ICMJE August 31, 2007
First Posted Date  ICMJE September 5, 2007
Results First Submitted Date  ICMJE January 31, 2011
Results First Posted Date  ICMJE April 18, 2011
Last Update Posted Date November 23, 2011
Study Start Date  ICMJE August 2007
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2011)
Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ]
Percent change in inflammatory lesion counts from Baseline to Week 12. It is calculated by taking the Week 12 count minus the Baseline count and then dividing by the Baseline count. Thus, a negative percent change will reflect a reduction in lesion counts.
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2007)
Acne lesion counts and Investigator's Global Assessment (IGA) [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT00525499 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2011)
Number of Participants With Improvement in Investigator Global Assessment by at Least One Grade From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ]
The Investigator Global Assessment used a static categorical scale, with zero corresponding to no acne and higher scores reflecting more severe acne: 0 No acne lesions.
  1. Rare non-inflammatory lesions.
  2. Some non-inflammatory lesions, no more than a few inflammatory lesions. No nodulo-cystic lesions.
  3. Many non-inflammatory lesions, some inflammatory lesions, no more than one nodulo-cystic lesion.
  4. Many noninflammatory and inflammatory lesions but no more than a few nodulo-cystic lesions.
  5. Highly inflammatory lesions, multiple nodulo-cystic lesions.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Study of ASC-J9 Cream in Acne Vulgaris
Official Title  ICMJE A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Dose-Ranging Clinical Study to Evaluate the Safety and Efficacy of ASC-J9 Cream Applied Twice Daily for 12 Weeks for the Treatment of Facial Acne Vulgaris
Brief Summary The purpose of this study is to evaluate if topical ASC-J9 cream is effective in treating acne.
Detailed Description Subjects with acne were randomized to one of four treatment groups for twice daily topical dosing to the face for 12 weeks. Assessments of acne status were performed at Baseline, Weeks 2, 4, 8 and 12 and then 4 weeks after the last dose of study drug.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: ASC-J9 cream
    Topical application to the face twice daily for 12 weeks.
  • Drug: placebo
    vehicle control applied topically twice daily for 12 weeks
    Other Name: Androgen receptor degradation enhancer
Study Arms  ICMJE
  • Placebo Comparator: 1
    Vehicle control cream applied topically to the face twice daily for 12 weeks
    Intervention: Drug: placebo
  • Experimental: 2
    0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
    Intervention: Drug: ASC-J9 cream
  • Experimental: 3
    0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
    Intervention: Drug: ASC-J9 cream
  • Experimental: 4
    0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
    Intervention: Drug: ASC-J9 cream
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2011)
186
Original Estimated Enrollment  ICMJE
 (submitted: August 31, 2007)
180
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At least 12 years of age.
  • Facial acne, with:

    20 -100 inflammatory facial lesions 20 -100 noninflammatory facial lesions No more than 2 nodules/cysts on the face

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • Skin diseases other than acne vulgaris
  • Use of oral retinoids within 6 months of Baseline Visit
  • Unwilling to discontinue all other treatments for facial acne
  • Unwilling to avoid excessive swimming/sun exposure and use of cosmetics
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00525499
Other Study ID Numbers  ICMJE ASC-J9-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AndroScience Corp
Study Sponsor  ICMJE AndroScience Corp
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Charles CY Shih, PhD AndroScience Corp
PRS Account AndroScience Corp
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP